What is baclofen?

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Generic Name: Baclofen Brand Name(s): Generics only. No brands available.

Know the basics

What is baclofen used for?

Baclofen is a muscle relaxer and an antispastic agent.

Baclofen is used to treat muscle symptoms caused by multiple sclerosis, including spasm, pain, and stiffness.

Baclofen may also be used for purposes not listed in this medication guide.

How should I take baclofen?

Take baclofen by mouth with or without food as directed by your doctor, usually 3 times a day. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor’s instructions carefully.

The dosage is based on your medical condition and response to treatment. Do not increase your dose or take it more often than prescribed.

Use baclofen regularly to get the most benefit from it. To help you remember, take it at the same times each day. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience withdrawal symptoms such as hallucinations and seizures. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

It may take 1 to 2 months or longer to get the full benefit from this medication. Tell your doctor if your condition does not improve or if it worsens.

How do I store baclofen?

Baclofen is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store baclofen in the bathroom or the freezer. There may be different brands of baclofen that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush baclofen down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Know the precautions & warnings

What should I know before using baclofen?

Before taking baclofen:

  • Tell your doctor and pharmacist if you are allergic to baclofen or any other drugs.
  • Tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially muscle relaxants, sleeping pills, tranquilizers, and vitamins.
  • Tell your doctor if you have or have ever had kidney disease, epilepsy, ulcers, a stroke, a rheumatic disease, cerebral palsy, parkinson’s disease, or a psychiatric condition.
  • Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking baclofen, call your doctor immediately.
  • You should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how baclofen affects you.
  • Remember that alcohol can add to the drowsiness caused by this drug.

Is it safe to take baclofen during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this medication during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking this medication. This medication is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown.

Know the side effects

What are the side effects of baclofen?

The most common is transient drowsiness (10-63%). In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) compared to 36% of those in the placebo group. Other common adverse reactions are dizziness (5-15%), weakness (5-15%) and fatigue (2-4%). Others reported:

Neuropsychiatric: Confusion (1-11%), headache (4-8%), insomnia (2-7%); and, rarely, euphoria, excitement, depression, hallucinations, paresthesia,muscle pain, tinnitus, slurred speech, coordination disorder, tremor, rigidity,dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis,diplopia, dysarthria, epileptic seizure.

Cardiovascular: Hypotension (0-9%). Rare instances of dyspnea, palpitation, chest pain, syncope.

Gastrointestinal: Nausea (4-12%), constipation (2-6%); and, rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool.

Genitourinary: Urinary frequency (2-6%); and, rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, hematuria.

Other: Instances of rash, pruritus, ankle edema, excessive perspiration, weight gain, nasal congestion.

Some of the CNS and genitourinary symptoms may be related to the underlying disease rather than to drug therapy. The following laboratory tests have been found to be abnormal in a few patients receiving baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) : increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Know the interactions

What drugs may interact with baclofen?

Baclofen may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alfentanil, Anileridine, Buprenorphine, Codeine, Fentanyl, Hydrocodone, Hydromorphone, Levorphanol, Meperidine, Methadone, Morphine, Morphine Sulfate, Liposome, Oxycodone, Oxymorphone, Propoxyphene, Remifentanil, Sodium Oxybate, Sufentanil, Suvorexant, Tapentadol.

Does food or alcohol interact with baclofen?

Baclofen may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with baclofen?

Baclofen may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have, especially:

  • Type 2 diabetes mellitus—Baclofen may raise blood sugar levels;
  • Epilepsy;
  • Kidney disease;
  • Mental or emotional problems;
  • Stroke or other brain disease—The chance of side effects may be increased.

Understand the dosage

The information provided is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist before using this medication.

What is the dose of Baclofen for an adult?

Usual Adult Dose of Baclofen for Muscle Spasm:

Initial dose: 5 mg orally 3 times a day for 3 days, then 10 mg orally 3 times a day for 3 days, then 15 mg orally 3 times a day for 3 days, then 20 mg orally 3 times a day.
Maintenance dose: 40-80 mg/day.
80 mg/day doses should be administered in 4 divided doses.

Intrathecal: Test dose: 50 mcg (in a volume of 1 mL) injected into the intrathecal space by barbotage over at least 1 minute. Observe patient for 4-8 hours for a positive response.
Second test dose: If no positive response to first test dose, 75 mcg (in a volume of 1.5 mL) may be administered 24 hours later.
Third test dose: If no positive response to second test dose, 100 mcg (in a volume of 2 mL) may be administered 24 hours later. If no positive response to third test dose, the patient should not be considered for chronic intrathecal therapy.
The test dose that received a positive response should be doubled and given over 24 hours. If the test dose maintained a positive response for > 12 hours, the starting daily dose should be the same as the effective test dose. After 24 hours, the dose may be titrated by 10%-20% increments every day until the desired clinical effect is achieved. Over time, many patients will require gradual dose increases to maintain the desired clinical effect. Patients have been maintained on daily doses of 12-1500 mcg. Most patients require 300-800 mcg/day.

Usual Adult Dose of Baclofen for Trigeminal Neuralgia:

Initial dose: 5 mg orally 3 times a day for 3 days, then 10 mg orally 3 times a day for 3 days, then 15 mg orally 3 times a day for 3 days, then 20 mg orally 3 times a day.
Maintenance dose: 40-80 mg/day.
80 mg/day doses should be administered in 4 divided doses.

Intrathecal: Test dose: 50 mcg (in a volume of 1 mL) injected into the intrathecal space by barbotage over at least 1 minute. Observe patient for 4-8 hours for a positive response.
Second test dose: If no positive response to first test dose, 75 mcg (in a volume of 1.5 mL) may be administered 24 hours later.
Third test dose: If no positive response to second test dose, 100 mcg (in a volume of 2 mL) may be administered 24 hours later. If no positive response to third test dose, the patient should not be considered for chronic intrathecal therapy.
The test dose that received a positive response should be doubled and given over 24 hours. If the test dose maintained a positive response for > 12 hours, the starting daily dose should be the same as the effective test dose. After 24 hours, the dose may be titrated by 10%-20% increments every day until the desired clinical effect is achieved. Over time, many patients will require gradual dose increases to maintain the desired clinical effect. Patients have been maintained on daily doses of 12-1500 mcg. Most patients require 300-800 mcg/day.

Usual Adult Dose of Baclofen for Hiccups:

Initial dose: 5 mg orally 3 times a day for 3 days, then 10 mg orally 3 times a day for 3 days, then 15 mg orally 3 times a day for 3 days, then 20 mg orally 3 times a day.
Maintenance dose: 40-80 mg/day.
80 mg/day doses should be administered in 4 divided doses.

Usual Adult Dose of Baclofen for Cerebral Spasticity:

Intrathecal: Test dose: 50 mcg (in a volume of 1 mL) injected into the intrathecal space by barbotage over at least 1 minute. Observe patient for 4-8 hours for a positive response.
Second test dose: If no positive response to first test dose, 75 mcg (in a volume of 1.5 mL) may be administered 24 hours later.
Third test dose: If no positive response to second test dose, 100 mcg (in a volume of 2 mL) may be administered 24 hours later. If no positive response to third test dose, the patient should not be considered for chronic intrathecal therapy.
If a positive response has occurred following a test dose, an intrathecal infusion device may be surgically implanted.
The test dose that received a positive response should be doubled and given over 24 hours. If the test dose maintained a positive response for > 12 hours, the starting daily dose should be the same as the effective test dose. After 24 hours, the dose may be titrated by 10%-20% increments every day until the desired clinical effect is achieved. Over time, many patients will require gradual dose increases to maintain the desired clinical effect. Patients have been maintained on daily doses of 12-1500 mcg. Most patients require 300-800 mcg/day.

What is the dose of Baclofen for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is baclofen available?

Baclofen is available in the following dosage forms and strengths:

Baclofen Tablets USP 10 mg are scored, round, white tablets imprinted DAN 5730 and 10 supplied in bottles of 100 and 500.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

The signs and symptoms of overdose include: Vomiting, muscular hypotonia, drowsiness,accommodation disorders, coma, respiratory depression, and seizures.

Treatment: In the alert patient, empty the stomach promptly by inducedemesis followed by lavage. In the obtunded patient, secure the airway with a cuffed endotracheal tube before beginning lavage (do not induce emesis). Maintain adequate respiratory exchange, do not use respiratory stimulants.

What should I do if I miss a dose?

If you miss a dose of baclofen, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: May 30, 2016 | Last Modified: January 4, 2017

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